Kornimate/medical-research-clean huggingface dataset:
a multi-site study of music therapy interventions on vitals, feeding and sleep in premature infants

Conditions: Prematurity; Sepsis; SGA; RDS

Summary: this is a multi-site study of 272 premature infants \>32 weeks who served in a randomized investigation (in morning or afternoon) where they served as their own controls. the infants' hr, rr, o2sats were measured with and without the implementation fo live music. the live interventions included songs of kin, selected by parents, the gato box and ocean disc played through entrained methods by a music therapist. the infants were evaluated within a two week period and in total each day including feeds, voids, activity level and sleep.


Eligibility criteria:
inclusion criteria: premature infants diagnosed with sga, rds and/or sepsis \>32 weeks referred by neonatologist irb hippa informed parent for infant consent obtained in writing exclusion criteria: infants with diagnoses other than the above

Keywords: music therapy entrainment premature infants live music intervention parent preferred lullabies
a study to evaluate safety and efficacy of telotristat etiprate (lx1606) in participants with acute, mild to moderate ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and preliminary effectiveness of two blinded dose levels of telotristat etiprate (lx1606) in participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of ulcerative colitis of at least 6 months duration * disease extends at least 15 cm proximally from the anal verge, documented within the past 3 years * flare occurs on 5-aminosalicylic acid (5-asa)/mesalamine therapy and subject is willing to remain on a stable dose for the duration of the study * age ≥18 and \<70 years of age * able and willing to provide written informed consent exclusion criteria: * prior terminal ileum or colonic surgery, except appendectomy or hemorrhoid surgery * presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of crohn's disease * clinical signs of fulminant colitis or toxic megacolon * history of dysplasia associated lesion or mass (dalm) * subjects who have had surgery for ulcerative colitis, or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study * history of primary sclerosing cholangitis * any physical or laboratory abnormality deemed by the investigator as clinically significant * major surgery within 60 days of screening * use of any investigational agent within 30 days of screening or any therapeutic protein or antibody within 90 days of screening
efficacy & tolerability of tobramycin podhaler in bronchiectasis patients with chronic pseudomonas aeruginosa infection

Conditions: Bronchiectasis With Chronic Infection With Pseudomonas Aeruginosa

Summary: the use of inhaled medications for the treatment of pulmonary diseases allows for the delivery of a high concentration of a drug at the site of disease with reduced systemic absorption and risk of systemic adverse effects. inhaled tobramycin has been successfully used in the maintenance treatment of cf patients with chronic colonization with pa (pseudomonas aeruginosa). in the cf population tobi has been proven to improve lung functions, decrease the density of the pa in the sputum, decrease hospitalizations, and reduce the risk of mortality. non cf bronchiectasis share many features in common with cf, including frequent colonization with pa that leads to deterioration in lung function and increased morbidity. a recent cochrane review concluded that there is a small benefit for the use of prolonged antibiotics in the treatment of bronchiectasis, however further randomized controlled trials with adequate power and standardized end points are required. there have been reports in the literature describing the efficacy of inhaled tobramycin the treatment of patients with non cf bronchiectasis with eradication of pa, and significant improvement in respiratory symptoms. there were however patients who discontinued treatment due to adverse events most commonly cough wheezing and dyspnea. (scheinberg and shore, chest 2005). tobi podhaler is a dry powder inhaler that was recently launched, and is much easier and faster to use compared to nebulised tobramycin. to the best of our knowledge tobramycin dry powder formulation has not yet been trialed in patients with non cf bronchiectasis. the purpose of this trial is to assess the efficacy and tolerability of tobi podhaler in patients with non cf bronchiectasis, and to gather more data on the benefit of continuous antibiotic therapy in patients with non cf bronchectais.


Eligibility criteria:
inclusion criteria: 1. patients with bronchiectasis confirmed by ct 2. chronic pa colonization with 2 documented sputum cultures positive for pa in the last 24 months. 3. age \>=18 exclusion criteria: 1. patients diagnosed with cf 2. patients who do not tolerate tobramycin 3. pregnant or breastfeeding 4. patients treated in the last 8 weeks with antibiotic therapy either inhaled or systemic (excluding azenil po x 3/week which is allowed)

Keywords: tobramycin podhaler bronchiectasis chronic infection pseudomonas aeruginosa
mindfulness based stress reduction for posttraumatic stress disorder: a pilot study

Conditions: Stress Disorders, Post-Traumatic; Depression

Summary: ptsd is a common consequence of war, for soldiers and civilians. ptsd results in hyperarousal, avoidance, numbing, and re-experiencing, causing persistent decreased quality of life. mindfulness involves the ability to bring attention to the present moment without judgment; this ability is correlated with measures of mental health. within health care, mindfulness is taught as an 8-week course called mindfulness-based stress reduction (mbsr). mbsr is unstudied for ptsd. we propose to assess the feasibility of mbsr as an intervention for ptsd, since it may affect hypervigilance, avoidance, and reactivity associated with this disorder. specific aims: aim 1: assess the feasibility of recruiting and retaining a sample of veterans with ptsd to complete a study protocol that involves randomization to usual care or usual care plus mbsr. aim 2: apply measures of ptsd symptom severity, depression and quality of life before and after randomization, to assess whether there is evidence of benefit and whether mbsr warrants further study for ptsd, and allow calculation of standardized effect sizes. aim 3: apply a validated measure of mindfulness before and after treatment. aim 4: explore the relationship between ptsd symptoms, mindfulness score, and frequency of meditation practice.


Eligibility criteria:
inclusion criteria: * must have ptsd exclusion criteria: * active substance use * active suicidal ideations * borderline or antisocial personality disorder

Keywords: stress mindfulness trauma
a prospective single-center randomized controlled trial of robotic surgery with transrectal resection specimens (noses-iv) and traditional assisted robotic surgery for the treatment of high rectal and sigmoid colon cancer

Conditions: Natural Orifice Specimen Extraction Surgery; Robotic Surgery; Short-term Outcomes

Summary: this study aimed to compare the short-term efficacy of robotic radical resection of high rectal cancer and sigmoid colon cancer (noses-iv) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer. at the same time, the safety and advantages of robotic radical resection of high rectal cancer and sigmoid colon cancer (noses-iv) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer were compared.


Eligibility criteria:
inclusion criteria: * 1) the age is more than 18 years old and less than or equal to 85 years old 2) eastern cooperative oncology group score ≤2 3) preoperative pathological diagnosis of rectal adenocarcinoma 4) ct1-3nxm0 rectal cancer defined by preoperative contrast-enhanced mri 5) the maximum diameter of tumor ≤5cm on preoperative enhanced mri 6) the body can tolerate the operation and sign the informed consent exclusion criteria: * 1) multiple primary colorectal cancer 2) recurrent rectal cancer 3) preoperative neoadjuvant chemoradiotherapy 4) complicated with intestinal obstruction or intestinal bleeding requiring emergency surgery 5) previous anal surgery history 6) bmi≥30kg/m2 7) severe mental illness
gdft on the postoperative outcome in head and neck cancer surgery

Conditions: Postoperative Complications

Summary: the goal of this clinical trial is to evaluate whether goal-directed fluid therapy (gdft) can improve the postoperative recovery in patients undergoing head and neck cancer surgery. it aims to answer is: • whether gdft can reduce the occurrence of serious postoperative complications? researchers will compare gdft protocol to a standard conventional fluid therapy in head and neck cancer surgery to see if gdft strategy works to improve the postoperative recovery. participants will * receive gdft protocol or a conventional fluid therapy during the surgery. * be continuously follow-up during hospitalization and after discharge to record the occurrence of postoperative complications.

postoperative complications have become the main cause of prolonged hospitalization and reduced postoperative survival rate among surgical patients. goal-directed fluid therapy (gdft) has been reported to reduce the incidence of postoperative complications and mortality, shorten the hospital stay, and improve the outcome in major abdominal surgery patients. however, the benefit of the gdft in patients undergoing head and neck surgery remains controversial. the purpose of this study is to evaluate whether gdft can reduce the occurrence of serious postoperative complications and shorten the postoperative hospital stay, compared with a standard conventional fluid therapy in patients undergoing head and neck cancer surgery.

Eligibility criteria:
inclusion criteria: * adult patients (age≥18) * scheduled to undergo head and neck cancer surgery (including nasopharyngeal carcinoma, laryngocarcinoma, hypopharyngeal carcinoma, and other head and neck malignancies, but not thyroid cancer) with an expected duration of 2 hours or longer * agree to receive invasive artery blood pressure monitoring exclusion criteria: * american society of anesthesiologists (asa) classification\>ⅳ * palliative surgery was performed for the terminal tumors * microlaryngoscopic laser surgery or endoscopic surgery * underwent major thoracic or abdominal surgery within 30 days * regular renal replacement therapy is required * nyha grade\>3 or ejection fraction \<30% * lung disease does not tolerate the tidal volume by 8 ml/kg * atrial fibrillation * unable to give informed consent * pregnant or lactating woman * emergency surgery

Keywords: postoperative complications early goal-directed therapy fluid therapy head and neck neoplasms
evaluation of cognitive impairment in the elderly admitted to nursing homes

Conditions: Neurocognitive Disorder, Etiology of Neurocognitive Disorder

Summary: this research aims at analysing the profile of the elderly with cognitive impairment (ic) and inquiring about the mental illnesses that cause cognitive impairment of a population (elderly admitted to nursing homes with a high incidence).

the objectives of these studies are to determine the presence of ic and the profile of users who suffer from it in 8 nursing homes in the province of pontevedra of new admission in 2017, as well as the identification of the frequency of underdiagnosis in the filiation of the mental pathology that causes ic and if that underdiagnosis is related to the presence of doctors or nurses specialists in geriatrics. sociodemographic, clinical (with special relevance in cognitive assessment and the presence of mental disorders) and functional variables will be analyzed. in addition to providing information that can improve the dc early detection as well as the scarcity of studies in this field, the importance of this research is justified by developing treatment guidelines for people with ic in the future

Eligibility criteria:
inclusion criteria: * vounteer * elderly admitted to nursing homes * from 60 years old exclusion criteria: * elderly without cognitive assessment at admission * existence of doubts about the presence of ic

Keywords: cognitive impairment, nursing home, neurocognitive disorder
a clinical trial to study the effect of lycopene in patients with gum disease and type2 diabetes mellitus

Conditions: Positive Regulation of Oxidative Stress Process

Summary: this study was performed to assess the efficacy of systemic lycopene (8 mgms daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus.

this study is a randomized double blinded clinical trial which was performed to assess the efficacy of systemic lycopene (8 mgms daily for two months) as an adjunct to scaling and root planing in chronic periodontitis patients with type 2 diabetes mellitus. the primary outcome measures were serum mda, crp and hb1ac. the secondary outcomes were modified gingival index(gi), probing pocket depth(ppd), and clinical attachment level(cal). all the outcomes were measured at baseline, 2 months and 6 months. the results were that the lycopene with scaling and root planing group gave: statistically significant results in reducing mean serum mda levels at 2 months and 6 months respectively.

Eligibility criteria:
inclusion criteria: type 2 diabetes * patients on oral hypoglycemic drugs with no modification in therapy from the past 12 months * chronic periodontitis as per aap (american academy of periodontology) guidelines * minimum of 15 natural teeth * at least four teeth with one or more sites with probing depth (pd) greater than or equal to 5 mm, clinical attachment level (cal) greater than or equal to 4mm and bleeding on probing (bop). exclusion criteria: history of antibiotic therapy within the previous 6 months * history of anti-inflammatory drugs within the previous 3 months * pregnancy and lactation * use of contraceptives or any other form of hormone * usage of tobacco and tobacco related products * periodontal treatment within 12 months.

Keywords: diabetes, periodontitis, oxidative stress, antioxidant
pain management of amputation wounds with autohypnosis

Conditions: Vascular Surgical Procedures

Summary: amputation in vascular surgery mainly concerns the lower limb and is often linked to obliterative arterial disease of the lower limbs. it indicates the impossibility or failure of revascularisation after an exhaustive assessment aimed at saving the limb. it is also performed to limit the spread of gangrene, an affection of the limb that can evolve into septicaemia. the principle is to amputate in a healthy and vascularised area to allow good healing of the amputation stump. amputations of one, several or all toes, called complete transmetatarsal amputations, may take several months to heal. amputations require directed healing and, above all, monitoring of the underlying tissues of the amputated area by daily detersions and wiping performed by a nurse at home. the mechanical detersion of the wound necessary for the healing process and cell migration, as well as optimal deep meshing, facilitate the evolution of the healing process. these treatments often cause pain, despite oral analgesics and local anaesthetics prior to the treatment. for several years, studies have shown the benefits of hypnosis in modifying the perception of pain, particularly during treatment. studies have also shown that self-hypnosis allows a reduction in the intensity of pain. the clinical experience of the vascular surgery department of the university hospital of rennes suggests that patients who use self-hypnosis during the daily dressing of their amputation experience the moment more serenely, increasing their comfort and decreasing their pain and anxiety.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * naïve to amputation procedures; * amputated, within 24 hours prior to inclusion, one, more or all toes * pain level on the numerical scale ≥ 3 during the first dressing; * affiliated to a social security scheme; * having signed a free, informed and written consent. exclusion criteria: * cognitive impairments that limit understanding of instructions; * cultural limitations reducing abstraction skills; * previous practice of hypnosis; * contraindications to hypnosis: bipolar disorder or decompensated schizophrenia; * chronic non-vascular pain; * already in care for painful chronic wounds (ulcer wounds, bedsores...) * on morphine before surgery; * analgesia by perineural catheter; * protected person (adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty, pregnant woman (declarative), nursing woman and minor).

Keywords: lower extremity artery disease self-hypnosis amputation care
a phase iii of covid-19 vaccine eucorvac-19 in healthy adults aged 18 years and older

Conditions: COVID-19

Summary: a phase iii, randomized, observer-blind, active-controlled, parallel-group, multi-center study to evaluate immunogenicity and safety of a preventive covid-19 vaccine eucorvac-19 in healthy adults aged 18 years and older


Eligibility criteria:
inclusion criteria: * individuals aged 18 years and older who voluntarily decide to participate in this study and provide written informed consent * female of childbearing potential who agree to use medically allowed methods of contraception during the study period * individuals who agrees not to perform blood donation and transfusion during the study period exclusion criteria: * individual being considered to be confirmed covid-19 * direct contact with covid-19 infected person within 14 days prior to the 1st dose of the ip * individuals at high risk of exposure to sars-cov-2 * individuals with clinically significant abnormalities in clinical laboratory tests, ecgs, and chest x-ray during screening * individuals with fever within 72 hours prior to the 1st dose of the ip or suspected other infectious disease or symptoms associated with other infectious disease * individuals with serious medical or psychiatric disease * history of sars-cov or mers-cov infection * history of allergic reaction or hypersensitivity reactions to any of components of the ip * history of serious adverse events, serious allergic reaction or serious hypersensitivity reactions to vaccination * history of receiving organ or bone marrow transplant * suspected or history of drug abuse or alcohol abuse within 6 months prior to vaccination * history of vaccination against sars-cov, mers-cov, or sars-cov-2 * history of vaccination with test vaccine substance * treatment with immunosuppressants or immune modifying drugs * history of treatment with antipsychotics or opioid dependence * pregnant or lactating women * other reasons based on which the individual is considered to be ineligible for this study in the opinion of the investigator
vaginal progesterone versus cervical cerclage for pregnant women with short cervix and history of ptl and/or mtm

Conditions: Premature Labour

Summary: the aim of this study to compare vaginal progesterone supplementation to cervical cerclage for prevention of preterm labor in women with short cervical length and history of previous midtrimester miscarriage and/or preterm labor.

women with singleton pregnancy and history of preterm labor and/or midtrimester miscarriage in a previous pregnancy will be selected for serial assessment of the cervical length by transvaginal sonography (tvs) starting from 16 weeks till 24 weeks of gestation. eligible participants in our study will be those who have cervical length of 15-25 mm at 16-24 weeks of gestation. at 16-24 weeks gestational age, all women participating in the study will be randomly allocated into two groups; progesterone group and cerclage group. for women in the progesterone group, vaginal progesterone suppositories will be given in a dose of 400 mg/day. for women in the cerclage group, mcdonald cervical cerclage will be performed.

Eligibility criteria:
inclusion criteria: * women with singleton pregnancy. * history of preterm labor and/or midtrimester miscarriage in a previous pregnancy. * cervical length of 15-25 mm by transvaginal sonography (tvs) at 16-24 weeks of gestation. exclusion criteria: * age \ 35 years. * congenital uterine malformation. * multifetal pregnancy. * known major fetal structural or chromosomal abnormality. * known allergy or contraindication (relative or absolute) to progesterone therapy. * presence of contraindication to cervical cerclage. * medical conditions complicating pregnancy. * vaginal bleeding.

Keywords: preterm labor short cervix progesterone cervical cerclage
piloting "positive peer journaling" a journaling practice to support recovery from addiction

Conditions: Addiction

Summary: the main objective of this study is development of the positive peer journaling (ppj) intervention and the feasibility, acceptability, and logistics of treatment delivery. a second objective is to observe whether ppj is associated with improvement in hypothesized outcomes. the primary outcomes the investigators will examine are enhanced treatment retention and reduced recurrence of substance use. the investigators will also explore the association between the intervention and a set of hypothesized mediators of the effect of the intervention on outcomes, e.g., improvement in mood and satisfaction with recovery.


Eligibility criteria:
inclusion criteria: * minimum 18 years of age, * meet dsm-v criteria for past-year sud as primary or secondary diagnosis, * english literacy sufficient to make short written lists needed to complete ppj and homework assessments, * minimum 2 weeks sustained abstinence, * completed first 2 weeks of treatment at wayside (approximately 2 weeks), a residential substance use disorder treatment program and the recruitment site, * priority will go to participants who are from or moving back to a rural area or small town defined as a population less than 10,500, * agree to be audio recorded in group meetings and in individual meetings with research staff, * currently are clients in the wayside residential program, * participants must be english speaking and literacy must be strong enough to write short lists and to understand the questions asked in the questionnaires. * priority will go to women who will be residing at wayside for the duration of the study activities (and not moving out after one week, for example). exclusion criteria: * presence of a psychotic disorder, psychiatric condition (e.g., suicidal ideation), or cognitive impairment (e.g., severe dementia, traumatic brain injury) limiting ability to give consent and/or participate in the study; * severe psychiatric illness (current schizophrenia, major depression with suicidal ideation); * personality disorders that would interfere with satisfactory participation in or completion of the study protocol, * inability to give informed, voluntary consent to participate, * lack of sufficient english literacy to participate, defined as inability to make a list of 5 things they did yesterday and inability to understand questionnaire items, * any impairment, activity, or situation that in the judgement of the research staff would prevent satisfactory participation in or completion of the study protocol.